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Study of GS-4528 in Adults With Solid Tumors
NCT05840224 · View on ClinicalTrials.gov ↗
Study Summary
The goals of this clinical study are to identify if GS-4528 alone or in combination with anti-programmed cell death protein 1 (PD-1) (Anti-PD-1) Monoclonal Antibody is safe and tolerable in people with solid tumors and to identify the recommended dose of GS-4528 for further development that is safe to give to people alone or in combination with Anti-PD-1 Monoclonal Antibody. The primary objectives of this study are: * To assess the safety and tolerability of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors. * To identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of GS-4528 as monotherapy and in combination with Anti-PD-1 Monoclonal Antibody in participants with advanced solid tumors.
Conditions Studied
Interventions
- DRUG Zimberelimab
- BIOLOGICAL GS-4528
Study Locations (16)
Other
- The Ottawa Hospital — Ottawa
- University Health Network, Princess Margaret Cancer Centre — Toronto
- Asan Medical Center — Seoul
- Severance Hospital, Yonsei University Health Systems — Seoul
- Samsung Medical Center — Seoul
- NEXT Oncology-Hospital Quironsalud Barcelona - Unidad de Ensayos Fase 1 — Barcelona
- Hospital Universitari Vall D'Hebron- Oncology Service — Barcelona
- START MADRID_Hospital Universitario Fundacion Jimenez Diaz - Unidad de Ensayos Fases I — Madrid
- START MADRID_HM Sanchinarro-CIOCC-Unidad de Ensayos Fases I — Madrid
- Clinica Universidad de Navarra- Unidad Central de Ensayos Clinicos — Pamplona
- Taichung Veterans General Hospital — Taichung
- National Taiwan University Hospital — Taipei
- Chang Gung Memorial Hospital Linkuo Branch of the Chang Gung Medical Foundation — Taoyuan District
- St Bartholomew's Hospital — London
- The Royal Marsden NHS Foundation Trust — Sutton
Washington
- The University of Washington/FHCC — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2023-05-11 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05840224
The ClinicalTrials.gov registry entry for NCT05840224 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 182 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 190 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 2 interventions — of which Zimberelimab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05840224 reports 16 study locations spanning 2 distinct geographic areas — top geographies include Other, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05840224 about?
NCT05840224 is a clinical study titled "Study of GS-4528 in Adults With Solid Tumors". The goals of this clinical study are to identify if GS-4528 alone or in combination with anti-programmed cell death protein 1 (PD-1) (Anti-PD-1) Monoclonal Antibody is safe and tolerable in people with solid tumors and to identify the recommended dose of GS-4528 for further development that is safe ...
What is the current status of trial NCT05840224?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 182 participants. The study started on 2023-05-11. Estimated completion is 2026-07.
What conditions does trial NCT05840224 study?
This clinical trial studies the following conditions: Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05840224?
The interventions under investigation include: Zimberelimab (DRUG), GS-4528 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05840224?
This trial is sponsored by Gilead Sciences, which has 190 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05840224 being conducted?
This trial has 16 study locations across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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